Tobacco products with cannabinoid additives and methods for reducing the harm associated with tobacco use

ABSTRACT

A substantially pure fraction of at least one cannabinoid is added to smokable or smokeless tobacco products to reduce the harm associated with tobacco use. The harm to be reduced includes irritation and carcinogenicity of tobacco. In a preferred embodiment a whole plant cannabis extract is mixed directly with the tobacco during the curing or manufacturing process. For cigarette applications the cannabinoids may be inserted into a cigarette filter, and/or paper. In other embodiments the cannabinoids are purified.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/451,377, filed Mar. 6, 2017, which claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 62/304,276, filed Mar. 6,2016, which is incorporated herein by reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

N/A

FIELD OF THE INVENTION

The present invention relates to tobacco products such as cigarettes,cigars, pipe tobacco (bulk), roll your own, and smokeless tobaccoproducts also known as “snuff,” “chewing tobacco,” and “dippingtobacco.” More particularly, novel forms of tobacco and tobacco productsincluding, cured and uncured leaves, which include as additives one ormore cannabinoids as health enhancing, harm reduction, and/or experienceenhancing agents.

BACKGROUND OF THE INVENTION

Health problems associated with cigarette smoking, cigar smoking, pipesmoking and smokeless tobacco have been well publicized. In variousscientific studies, cigarette smoking, cigar smoking, pipe smoking anduse of smokeless tobacco have been causally linked to diseases such aslung, throat, mouth and other cancers as well as emphysema, smoker'scough and heart disease.

Various attempts have been made to address cigarette health problemsthrough reformulation of cigarettes. For example, special blends oftobacco have been formulated for cigarettes with reduced levels of tarand nicotine. Unfortunately, each reduction of the tar and nicotinelevel has been accompanied by a corresponding reduced level of usersatisfaction requiring unhealthy longer, stronger puffs to increasesmoker's satisfaction. As such, sales of lowered tar and nicotinecigarettes, particularly those commercially classified as “ultra low tarand nicotine”, have not lived up to expectations. More recently, effortshave been made to altogether remove additives from cigarettes. Whilesuch “additive free” cigarettes may provide a purer tobacco smoke, it isunclear whether they provide any corresponding health benefits. In fact,in some cases, they have been shown to be stronger in tar and nicotinesince they contain relatively more tobacco than non-additive containingcigarettes.

SUMMARY OF THE INVENTION

As specified in the Background Section above, there is a need in the artto develop new tobacco additives to reduce the harm associated withtobacco use and improve user experience with tobacco.

Thus According to a first aspect of the present invention there isprovided an effective technique for adding cannabinoids to cigarettes,cigars, bulk tobacco (including leaves), reconstituted tobacco, pipetobacco and smokeless snuff, “moist snuff” or “chewing” tobacco (assmokeless tobacco is commonly known) as well as to non-tobacco smokableand mouthable products. In an embodiment the cannabinoid added to thetobacco is (tetrahydrocannbinol) THC. In another embodiment, thecannabinoid is cannabidiol (CBD). In another embodiment the cannabinoidis selected from the group consisting of tetrahydrocannabinolic acid(THCA), Cannabidiolic acid (CBDA), cannabinol (CBN), cannabigerol (CBG),cannabichromene (CBC), tetrahydrocannabivarin (THCV), and cannabidivarin(CBDV). In another embodiment the cannabinoid is a combination of two ormore of the cannabinoids listed herein.

According to a second aspect the invention there is provided a tobaccoproduct selected from the group consisting of cigarettes, cigars, bulktobacco (including leaves), reconstituted tobacco, pipe tobacco andsmokeless snuff or “chewing” tobacco (as smokeless tobacco is commonlyknown) as well as to non-tobacco smokable and mouthable products,further comprising the addition of one or more cannabinoids selectedfrom the group consisting of tetrahydrocannabinol (THC), cannabidiol(CBD), tetrahydrocannabinolic acid (THCA), Cannabidiolic acid (CBDA),cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC),tetrahydrocannabivarin (THCV), and cannabidivarin (CBDV).

According to a third aspect of the invention there is provided a methodfor reducing the harm associated with tobacco use in a subject in needthereof comprising the steps of providing to that user a tobacco productfurther comprising the addition of one or more cannabinoids selectedfrom the group consisting of tetrahydrocannabinol (THC), cannabidiol(CBD), tetrahydrocannabinolic acid (THCA), Cannabidiolic acid (CBDA),cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC),tetrahydrocannabivarin (THCV), and cannabidivarin (CBDV).

Preferred features of the invention will now be described in furtherdetail. Features described as being preferred in relation to one aspectof the invention apply mutatis mutandis to all other aspects, unlessclearly stated otherwise.

The cannabinoids used may be isolated using any methods known by thosehaving skill in the art, including the use of hydrocarbon solvents andsolventless extraction. Therefore in one embodiment the cannabinoidsused as additives are produced by extraction of cannabis plant materialwith supercritical or subcritical CO2. In an alternative embodiment thecannabinoid additives are produced by extraction from plant material byvolatilisation with a heated gas. In an alternative embodiment thecannabinoid additives are produced from plant material through thesequential processes of CO2 extraction followed by fractionaldistillation. In some embodiments, the cannabinoid additives contain allof the naturally occurring cannabinoids in the plant material.Alternatively, synthetic or highly purified isolates of the cannabinoidscan be used.

The term “approximately equal” is used to refer to ratios ofcannabinoids which are in the range of between 0.9:1 to 1:0.9 (THC:CBD).Additionally the term “1:1” is taken herein to refer to approximatelyequal amounts of cannabinoids.

DETAILED DESCRIPTION

These and other systems, methods, objects, features, and advantages ofthe present disclosure will be apparent to those skilled in the art fromthe following detailed description of the embodiments and drawings.

All documents mentioned herein are hereby incorporated in their entiretyby reference. References to items in the singular should be understoodto include items in the plural, and vise versa, unless explicitly statedotherwise or clear from the text. Grammatical conjunctions are intendedto express any and all disjunctive and conjunctive combinations ofconjoined clauses, sentences, words, and the like, unless otherwisestated or clear from context

The cannabinoids are a class of molecules primarily obtained through theextraction of cannabis plant material. The various cannabinoids includetetrahydrocannabinol (THC), cannabidiol (CBD), tetrahydrocannabinolicacid (THCA), Cannabidiolic acid (CBDA), cannabinol (CBN), cannabigerol(CBG), cannabichromene (CBC), tetrahydrocannabivarin (THCV), andcannabidivarin (CBDV) as well as others. Various cannabinoids, usedalone or in combination have shown a variety of significant biologicaleffects including but not limited to pain relief, anti cancer, antiinflammatory, anti emetic, anti convulsant, and several others.

With respect to cannabinoid additives for tobacco, CBD is particularlyuseful due to its non-intoxicating, antineoplastic, anti-inflammatory,and pain relieving effects. While specific embodiments of tobaccoproducts including cannabinoids are discussed with respect to CBD, it isnoted that other cannabinoids may be added to or substituted dependingon the specific effects desired from the additives. Therefore, in anembodiment, a substantially pure, dry powder of CBD is mixed directlywith the tobacco used in smokable or smokeless tobacco during themanufacturing process and/or directly into smokable or smokeless tobaccoproducts. CBD can also be inserted or mixed into mixtures of laminatobaccos, reconstituted tobacco and lamina tobacco mixed withreconstituted tobacco as well as into a cigarette filter, holder, paperor wrapper. One may also place the additive in tobacco prior to curingso long as it will remain stable enough to sustain its benefits all theway through processing and in storage. Other forms of cannabinoidadditives, namely oils can be used in the present invention. Oils may beparticularly useful do the fact that it is difficult to getsubstantially pure, solid forms of many cannabinoids. Oils may beparticularly useful in chewing tobacco, and as a coating for theinterior surface of cigarette and cigar wrappers. Other formulations ofcannabinoids may be incorporated into tobacco products such asmicroencapsulated, particleized cannabinoids.

Cannabinoids can be incorporated into a tobacco or non tobacco productin a number of different ways including being directly mixed with thetobacco or inserted into a cigarette/cigar filter, holder, or wrappereither in a dry, oil, or microencapsulated form. In an embodiment of thepresent invention, a substantially pure, “dry” form of CBD can beblended into, sprayed or dusted onto the full or cut tobacco ornon-tobacco leaves during the curing or manufacturing process. In thatway, the substantially pure, “dry” form of CBD will already beincorporated onto the tobacco when it is rolled into the cigarettepackaged in a bulk smokeless container. While the quantity of CBD to beused in this process can vary, it is expected that between 0.1 and 5000milligrams of CBD or other cannabinoid would be a suitable amount for acigarette or smokeless tobacco wad containing 400-1200 milligrams oftobacco, with a more preferred amount of CBD or other cannabinoid to bebetween 0.1% to 20.0% by weight of tobacco or 0.4 milligrams to 240milligrams for a cigarette or smokeless tobacco wad containing 400-1200milligram of tobacco. In some embodiments the cannabinoids are added byadding an amount of a whole plant cannabis extract.

In another embodiment the tobacco and cannabinoid additives are providedas a kit comprising separate portions of tobacco and cannabinoidextracts, enabling users to combine the tobacco and cannabinoidadditives in proportions of their choosing.

In another embodiment, the cannabinoid(s) are incorporated into thecigarette filter either as dispersed particles, liquid infused into thefilter medium or microencapsulated particles. The cannabinoid(s) mayalso be incorporated into tobacco paper, plug wrap, and or filter paper.

In other embodiments, the cannabinoid(s) are added to the tobacco afterthe tobacco has been dried, cured and otherwise processed to be readyfor formulation into cigarettes, smokeless and other forms. The additionof cannabinoids at this stage is beneficial as it avoids the possibilityof degradation of the cannabinoids over time and during the processingsteps of the raw tobacco leaves. It also has the added benefit ofenabling a more accurate and precise dosage of cannabinoid(s).

In some embodiments terpenes, either alone or in combination withcannabinoids are added as additives to the tobacco products.

In some embodiments the cannabinoids present as additives are THC andCBD present in ratios in the range of 1:100 to 100:1, particularlybetween 1:20 to 20:1. In some embodiments the cannabinoids present areTHC and CBD in a 1:1 ratio.

There are several benefits associated with cannabinoid additives totobacco products, especially as a harm reduction measure. One benefit isthe reduced irritation associated with tobacco product use. Inparticular, the addition of CBD, with its known anti inflammatory andpain relieving properties is particularly beneficial in reducing some ofthe discomfort associated with tobacco use. The use of THC as anadditive to tobacco products is beneficial, especially in states wherethe recreational use of cannabis is permitted and as a way to reduce thenausea that sometimes accompanies tobacco use.

The use of cannabinoids as tobacco additives, may be particularly usefulas a mechanism to reduce the carcinogenicity associated with tobaccoproducts. Substantial evidence has been presented that these compoundscan reduce tumor growth in animal models of cancer. A large body ofscientific evidences strongly support THC and other cannabinoid agonistsexert anticancer actions in preclinical models of cancer (includingimmunocompetent mice) through a well-established mechanism of action.See ie The Use of Cannabinoids as Anticancer Agents—Velasco et al.Progress in Neuro-Psychopharmacology and Biological Psychiatry, Jan. 42016, which is hereby incorporated by reference in its entirety.

The use of cannabinoids as tobacco additives, may be particularly usefulas a mechanism to reduce the inflammatory response often caused by theuse of tobacco products. Tobacco use is known to cause variousinflammatory responses including but not limited to inflammation andirritation of the mouth and throat. Various cannabinoids are known tohave an anti-inflammatory effect. See ie Comparative topicalanti-inflammatory activity of cannabinoids and cannbivarins—Tubaro etal. Fitoterapia, (2010) 816-819, which is hereby incorporated byreference in its entirety.

Therefore, In one embodiment, the invention is a smokable or nonsmokable composition comprising tobacco and at least one additiveselected from the group consisting of tetrahydrocannabinol (THC),cannabidiol (CBD), tetrahydrocannabinolic acid (THCA), Cannabidiolicacid (CBDA), cannabinol (CBN), cannabigerol (CBG), cannabichromene(CBC), tetrahydrocannabivarin (THCV), and cannabidivarin (CBDV).

Another embodiment is, method of reducing the harm associated withtobacco use comprising providing tobacco users with tobacco products towhich have been added at least one cannabinoid selected from the groupconsisting of tetrahydrocannabinol (THC), cannabidiol (CBD),tetrahydrocannabinolic acid (THCA), Cannabidiolic acid (CBDA),cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC),tetrahydrocannabivarin (THCV), and cannabidivarin (CBDV). In some casesthe harm associated with tobacco use that is to be reduced is theinflammation that is associated with tobacco use. In some cases the harmassociated with tobacco use that is to be reduced is the carcinogenicityof tobacco. In some cases the harm associated with tobacco used that isto be reduced is the mouth discomfort associated with the use ofsmokeless tobacco.

Another embodiment is a tobacco mixture with a reduced carcinogenicityprofile comprising tobacco with a cannabinoid additive selected from thegroup consisting of tetrahydrocannabinol (THC), cannabidiol (CBD),tetrahydrocannabinolic acid (THCA), Cannabidiolic acid (CBDA),cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC),tetrahydrocannabivarin (THCV), and cannabidivarin (CBDV).

Another embodiment is method for reducing free radical damage to theoro-pharyngeal cavity, respiratory tract and lungs from tobacco smoke,the method comprising adding a cannabinoid additive to tobacco products,the additive selected from the group consisting of tetrahydrocannabinol(THC), cannabidiol (CBD), tetrahydrocannabinolic acid (THCA),Cannabidiolic acid (CBDA), cannabinol (CBN), cannabigerol (CBG),cannabichromene (CBC), tetrahydrocannabivarin (THCV), and cannabidivarin(CBDV).

Another embodiment is a cigarette comprising a paper wrapper surroundinga charge of tobacco, said cigarette further comprising a composition forreducing free radical damage to the oro-pharyngeal cavity, respiratorytract and lungs from tobacco smoke generated by said cigarette, saidcomposition comprising a cannabinoid additive to tobacco products, theadditive selected from the group consisting of tetrahydrocannabinol(THC), cannabidiol (CBD), tetrahydrocannabinolic acid (THCA),Cannabidiolic acid (CBDA), cannabinol (CBN), cannabigerol (CBG),cannabichromene (CBC), tetrahydrocannabivarin (THCV), and cannabidivarin(CBDV).

While the present disclosure includes many embodiments shown anddescribed in detail, various modifications and improvements thereon willbecome readily apparent to those skilled in the art. Accordingly, thespirit and scope of the present invention is not to be limited by theforegoing examples, but is to be understood in the broadest senseallowable by law.

With respect to the above, it is to be understood that the invention isnot limited in its application to the details of construction and to thearrangement of the components listed or the steps set forth in thedescription or illustrated in the drawings. The various apparatus andmethods of the disclosed invention are capable of other embodiments, andof being practiced and carried out in various ways that would be readilyknown to those skilled in the art, given the present disclosure.Further, the terms and phrases used herein are for descriptive purposesand should not be construed as in any way limiting.

As such, those skilled in the art will appreciate that the conceptionupon which this disclosure is based may be utilized as a basis fordesigning other inventions with similar properties. It is importanttherefore that the embodiments, objects, and claims herein, be regardedas including such equivalent construction and methodology insofar asthey do not depart from the spirit and scope of the present invention.

What is claimed is:
 1. A method for reducing the harmful effects oftobacco use in a human in need thereof, comprising: administering to thehuman in need thereof tobacco and a cannabinoid from cannabis toeffectively reduce the harmful effects of tobacco use in the human inneed thereof, wherein said cannabinoid is selected from the groupconsisting of tetrahydrocannabinol, cannabidiol and mixtures thereof. 2.The method of claim 1 wherein tetrahydrocannabinol and cannabidiol arepresent in a ratio of about 1:20, tetrahydrocannabinol:cannabidiol, whenused as a mixture.
 3. The method of claim 1 wherein said tobacco is in aform selected from the group consisting of cigarettes, cigars, chewingtobacco, and moist snuff.
 4. The method of claim 1 wherein thecannabinoid is a microencapsulated, highly purified cannabinoid isolatemixed with said tobacco prior to administration.
 5. A kit for reducingthe harmful effects of tobacco use in a human in need thereof,comprising: a first component including tobacco provided in apre-packaged form; a second component including a cannabinoid compoundprovided in a pre-packaged form; an optional container; and an optionalinsert comprising instructions for use of the kit wherein all orportions of said first and second components are combined into a newcomposition by a user prior to administration.
 6. The kit of claim 5wherein the second component includes tetrahydrocannabinol andcannabidiol present in a ratio of about 1:20,tetrahydrocannabinol:cannabidiol, when used as a mixture.
 7. The kit ofclaim 5 wherein said new assembly is selected from the group consistingof cigarettes, cigars, chewing tobacco, and moist snuff.
 8. The kit ofclaim 5 wherein the cannabinoid compound includes a microencapsulated,highly purified cannabinoid isolate.
 9. A method of reducing freeradical damage to the oropharyngeal cavity, respiratory tract and lungsof a human in need thereof, comprising: administering to the human inneed thereof tobacco and a cannabinoid from cannabis to effectivelyreduce free radical damage caused by tobacco use in the human in needthereof, wherein said cannabinoid is selected from the group consistingof tetrahydrocannabinol, cannabidiol and mixtures thereof.
 10. Themethod of claim 9 wherein tetrahydrocannabinol and cannabidiol arepresent in a ratio of about 1:20, tetrahydrocannabinol:cannabidiol, whenused as a mixture.
 11. The method of claim 9 wherein said tobacco is ina form selected from the group consisting of cigarettes, cigars, chewingtobacco, and moist snuff.
 12. The method of claim 9 wherein thecannabinoid is a microencapsulated, highly purified cannabinoid isolatemixed with said tobacco prior to administration.
 13. A method ofreducing a carcinogenic potential of tobacco use in a human in needthereof, comprising: administering to the human in need thereof tobaccoand a cannabinoid from cannabis to effectively reduce the carcinogenicpotential of tobacco use in the human in need thereof, wherein saidcannabinoid is selected from the group consisting oftetrahydrocannabinol, cannabidiol and mixtures thereof.
 14. The methodof claim 13 wherein tetrahydrocannabinol and cannabidiol are present ina ratio of about 1:20, tetrahydrocannabinol:cannabidiol, when used as amixture.
 15. The method of claim 13 wherein said tobacco is in a formselected from the group consisting of cigarettes, cigars, chewingtobacco, and moist snuff.
 16. The method of claim 13 wherein thecannabinoid is a microencapsulated, highly purified cannabinoid isolatemixed with said tobacco prior to administration.